Audio Data Collection for Identification and Classification of Coughing

Healthy Clinical Trial

Official title:

Audio Data Collection for Identification and Classification of Coughing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04326309
• Other study ID #: HM070102
• Status: Completed
• Start date: March 25, 2020
• Est. completion date: January 24, 2022

Study information

• Verified date: April 2022
• Source: HealthMode Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An open access study that will define and collect digital measures of coughing in multiple populations and public spaces using various means of audio data collection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 336
• Est. completion date: January 24, 2022
• Est. primary completion date: January 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Cohort 1, 3, 4 and 5:

• Females and males over 18 years old
• Willing to share demographic data with the sponsor of the study
• Willing to follow app use instructions during the course of the study
• Willing to complete survey instruments as described in study procedures
• Willing to provide electronic informed consent
• Able to read and understand the English language well enough to complete electronic informed consent Cohort 2: Any person present in the vicinity of a HealthMode Cough Monitoring Device Exclusion Criteria: No exclusion criteria -

Related Conditions & MeSH terms

• Asthma
• Chronic Obstructive Pulmonary Disease
• Common Cold
• Communicable Diseases
• Coronavirus Infections
• COVID-19
• Hay Fever
• Healthy
• Infections
• Influenza
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections
• Rhinitis, Allergic, Seasonal

Locations

Country	Name	City	State
United States	Virtual Facility	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
HealthMode Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dataset size	Size of collected audio dataset measured as number of collected cough sounds, targeting =10,000 identified coughs.	14 days
Secondary	Cough sound identification	Identification of cough sounds by the existing mathematical model with = 99% specificity and = 60% sensitivity	14 days
Secondary	Improvement of the existing model	Increase in the sensitivity of the mathematical model to cough sounds to = 70% while retaining the specificity of = 99%	14 days
Secondary	Evaluate the usability of the application	Determination of the level of acceptance and satisfaction of the solution by patients by means of a Standard Usability Questionnaire to provide feedback. The score ranges from 10 to 50, higher score indicating a better usability.	14 days